OncoMatch/Clinical Trials/NCT06492616
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Is NCT06492616 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for breast cancer.
Treatment: Elacestrant · Anastrozole · Letrozole · Exemestane · Tamoxifen — The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER-positive, ≥ 10% by IHC) (≥ 10% by IHC)
ER-positive (≥ 10% by immunohistochemistry [IHC])
Required: HER2 (ERBB2) negative (IHC = 0, 1+, 2 and ISH-negative) (IHC = 0, 1+, 2 and ISH-negative)
HER2-negative [IHC = 0, 1+, 2 and in situ hybridization [ISH]-negative)]
Prior therapy
Must have received: endocrine therapy (aromatase inhibitor, tamoxifen) — adjuvant
Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Southern Cancer Center, PC · Daphne, Alabama
- Ironwood Cancer and Research Centers · Chandler, Arizona
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Mayo Clinic · Scottsdale, Arizona
- Arizona Clinical Research Center, Inc. · Tucson, Arizona
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06492616 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received endocrine therapy.
Does this trial require ESR1?
Yes, ESR1 overexpression (ER-positive, ≥ 10% by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC = 0, 1+, 2 and ISH-negative) is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages